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Adolescent Mood During Puberty and Testosterone

Probing the Neurophysiological Mechanisms Underlying Sex-specific Testosterone-mood Relationships During Puberty: A Randomized Controlled Trial Using a Smartphone-based Training Program

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06072677
Acronym
AMPT
Enrollment
60
Registered
2023-10-10
Start date
2023-08-24
Completion date
2027-12-31
Last updated
2026-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adolescent Depression

Keywords

Puberty, Depression, Mood disturbance, Adolescence, Stress, Peripubertal Transition, Hormones, EEG, Sex differences

Brief summary

Starting at puberty, female adolescents are nearly three-times more likely to develop internalizing disorders, like depression, while male adolescents are two-times more likely to develop externalizing disorders, like attention deficit hyperactivity disorder (ADHD). This divergence between the sexes during puberty suggests sex-specific pathways of risk and differential effects of sex hormones. The purpose of this research is to determine: 1) sex-specific neural and endocrine features of the pubertal transition that may mediate sex differences in adolescent mood disorders, and 2) the neurophysiological basis of susceptibility to hormone change during puberty.

Interventions

The Healthy Minds Program is a 4-week mobile program to improve coping and emotion regulation skills. It includes 4 training modules corresponding to key pillars of wellbeing: awareness(focused attention/awareness of thoughts/emotions), connection (empathy, compassion, social connection), insight (clarity of identify/experience) and purpose (applying values/motivations). The Healthy Minds Program includes 2 introductory audio lessons and guided meditations, and each 1-week module includes 2 podcast lessons (5-7 minutes) with psychoeducation and practical examples, and 3 guided meditations relevant to the module topic, for a total of 10 lessons and 14 guided meditations.

Sponsors

Foundation of Hope, North Carolina
CollaboratorOTHER
University of North Carolina, Chapel Hill
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
11 Years to 14 Years
Healthy volunteers
Yes

Inclusion criteria

* Between the ages of 11 and 14 * Have their own personal mobile device and capability to download the MyCap and Healthy Minds apps * Experienced a stressful life event within the last year, or endorse moderate depression (defined by a CES-DC score 16 or higher)

Exclusion criteria

* Previous experience with the Healthy Minds Program * Regular meditation practice * Current or history of manic episodes, psychotic symptoms, or current suicidal intent * Taking any form of exogenous hormones or intrauterine device (IUD) within one month of participation in the study * Taking medications that directly alter cardiovascular or neurological function

Design outcomes

Primary

MeasureTime frameDescription
CES-DC Score Over Timeup to Week 8The 20-item Center for Epidemiological Studies Depression Scale for Children (CES-DC) will be the primary measure of severity of depressive symptoms. Each item is rated 0 (not at all) to 3 (a lot), with items 4, 8, 12, and 16 being reversed scored. The total CES-DC score may range from 0-60. Higher scores indicate more severe depressive symptoms. Scores of 15 or greater are suggestive of significant depressive symptoms. The overall CES-DC score will be assessed at the end of each week in the study.

Countries

United States

Contacts

Primary ContactKayla Jensen, BS
nerdlab@unc.edu919-445-6815

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026